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940733

Jubilant Cadista Pharmaceuticals — FEI 3017221809

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 7, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Yardley, PA (United States)

Facility

Other inspections at this facility

  • 1257696 (VAI Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120136 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064090 (NAI Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888209 (NAI Tue Jul 08 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842669 (NAI Thu Aug 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
135821 CFR 211.100(b)SOPs not followed / documented
139621 CFR 211.42(c)(2)Rejected Material Area
203121 CFR 211.194(a)Complete test data included in records
360321 CFR 211.160(b)Scientifically sound laboratory controls
363921 CFR 211.204Returned drug procedures in writing and followed